Tmj/jaw Formula™

Tmj/jaw Formula™
SPL v1
SPL
SPL Set ID 5c6e28ba-1f1d-493f-b6f6-325d1ff5cc6f
Route
ORAL
Published
Effective Date 2015-03-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Baptisia Tinctoria Root (10 [hp_X]) Fluoride Ion Causticum Calcium Sulfide Hypericum Perforatum Strychnos Ignatii Seed Kalmia Latifolia Leaf Strychnos Nux-vomica Seed Phytolacca Americana Root Toxicodendron Pubescens Leaf Sanguinaria Canadensis Root Comfrey Root
Inactive Ingredients
Water Anhydrous Citric Acid Potassium Sorbate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2012-11-06

Description

Drug Facts ​__________________________________________________________________________________________________________ HPUS active ingredients:  ​Baptisia tinctoria, Calcarea fluorica, Causticum, Hepar sulphuris calcareum, Hypericum perforatum, Ignatia amar, Kalmia latifolia, Nux vomica, Phytolacca decandra, Rhus toxicodendron, Sanguinaria canadensis, Symphytum officinale. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.


Medication Information

Warnings and Precautions

Warnings

  • Stop use and ask your doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, take only on advice of a healthcare professional.
Indications and Usage

Uses for temporary relief of: facial pains of the jaw, facial neuralgias, rigid jaw muscles, inflammation in the jaw, clenching of the jaw, cracking sounds.

Dosage and Administration

Directions

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Adults 12 and up: 3 sprays 3 times per day
  • Children 2-12: 2 sprays 3 times per day
  • Children 2 mo.-2 yr: 1 spray 3 times per day.
Description

Drug Facts ​__________________________________________________________________________________________________________ HPUS active ingredients:  ​Baptisia tinctoria, Calcarea fluorica, Causticum, Hepar sulphuris calcareum, Hypericum perforatum, Ignatia amar, Kalmia latifolia, Nux vomica, Phytolacca decandra, Rhus toxicodendron, Sanguinaria canadensis, Symphytum officinale. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

Section 50565-1
  • Keep out of reach of children.
Section 51727-6

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

Section 51945-4

Section 55105-1

Uses ​for temporary relief of:

  • facial pains of the jaw
  • facial neuralgias
  • rigid jaw muscles
  • inflammation in the jaw
  • clenching of the jaw
  • cracking sounds
Section 55106-9

Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients: ​Baptisia tinctoria, Calcarea fluorica, Causticum, Hepar sulphuris calcareum, Hypericum perforatum, Ignatia amar, Kalmia latifolia, Nux vomica, Phytolacca decandra, Rhus toxicodendron, Sanguinaria canadensis, Symphytum officinale. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

Section 60561-8

Tamper resistant for your protection . Use only if safety seal is intact. This product has not been clinically tested.


Structured Label Content

Indications and Usage (34067-9)

Uses for temporary relief of: facial pains of the jaw, facial neuralgias, rigid jaw muscles, inflammation in the jaw, clenching of the jaw, cracking sounds.

Dosage and Administration (34068-7)

Directions

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Adults 12 and up: 3 sprays 3 times per day
  • Children 2-12: 2 sprays 3 times per day
  • Children 2 mo.-2 yr: 1 spray 3 times per day.
Warnings and Precautions (34071-1)

Warnings

  • Stop use and ask your doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, take only on advice of a healthcare professional.
Section 50565-1 (50565-1)
  • Keep out of reach of children.
Section 51727-6 (51727-6)

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses ​for temporary relief of:

  • facial pains of the jaw
  • facial neuralgias
  • rigid jaw muscles
  • inflammation in the jaw
  • clenching of the jaw
  • cracking sounds
Section 55106-9 (55106-9)

Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients: ​Baptisia tinctoria, Calcarea fluorica, Causticum, Hepar sulphuris calcareum, Hypericum perforatum, Ignatia amar, Kalmia latifolia, Nux vomica, Phytolacca decandra, Rhus toxicodendron, Sanguinaria canadensis, Symphytum officinale. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

Section 60561-8 (60561-8)

Tamper resistant for your protection . Use only if safety seal is intact. This product has not been clinically tested.


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Raw Label Data

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